FDA Label for Prosoria Scalp

View Indications, Usage & Precautions

Prosoria Scalp Product Label

The following document was submitted to the FDA by the labeler of this product Nuvothera, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by Nuvothera, Inc.
Fort Worth, Texas 76104


Active Ingredient



Salicylic acid, 1.8%


Purpose



Antipsoriasis, antiseborrheic


Uses



relieves and helps prevent recurrence of symptoms of psoriasis and/or seborrheic dermatitis including:

  • scaling
  • flaking
  • itching
  • redness
  • irritation

Warnings



For external use only


Otc - When Using



When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.


Otc - Stop Use



Stop use and consult a doctor if the condition worsens or does not improve after regular use of this product as directed.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • apply and massage well on affected areas of the scalp once daily or as directed by a doctor. Tip bottle and apply small drops to affected area of the scalp and spread evenly. Let dry and leave on. Shampoo hair when needed.

Other Information



  • store at room temperature 59-77°F (15-25°C).

Inactive Ingredients



Water, Petrolatum, Ethoxydiglycol, Oleth-3 Phosphate, Butylene Glycol, Tetrahydrodiferuloylmethane, Polyacrylate Crosspolymer-6, Sodium Hydroxide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Curcuma Longa (Turmeric) Root Extract, Nigella Sativa Seed Oil, Polyisobutene, Cyclodextrin, Undecylenoyl Glycine, Phenoxyethanol, Capryloyl Glycine, Disodium EDTA, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid.


Questions?



Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.


Principal Display Panel - 74 Ml Bottle Label



treats

prosoriä

scalp lotion

1.8% salicylic acid

anti-psoriasis
anti-seborrheic

2.5 FL OZ (74mL)


* Please review the disclaimer below.